Cocaine Opioid Oxytocin Option - Limited

Phase 1

Completed

• Conditions: Cocaine Use Disorder; Opioid Use Disorder
• Interventions: Drug: Placebo; Drug: Oxytocin

• Registration Number: NCT02028533
• Lead Sponsor: University of California, San Francisco

Brief Summary

This is a pilot feasibility study assessing the tolerability of chronic administration of intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are actively using cocaine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-03
• Study First Submitted QC: 2014-01-03
• Study First Posted: 2014-01-07
• Study Start: 2014-07
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Enrolled as a patient in the San Francisco General Hospital Opioid Treatment Outpatient Program
• Stable dose of methadone for at least the past two weeks
• At least one routine urine toxicology screen positive for cocaine in the past month

Exclusion Criteria

• Positive urine pregnancy test
• Use of illicit drugs in the past month (with the exception of cocaine or cannabis)
• Currently meets Diagnostic and Statistical Manual-5 (DSM-V) criteria for severe major depressive disorder with suicidal thoughts or actions
• History of psychotic or moderate-severe alcohol use disorder as defined by DSM-V criteria
• Severe neuropsychological disorder, brain trauma, epilepsy
• Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate)
• Nasal obstruction, discharge, or bleeding
• Habitually drinks large volumes of water
• Taking testosterone, estrogen/progesterone supplement, or serotonin-1a receptor agonists/antagonists

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients 2	Placebo	Participants will receive 40 International Units of intranasal placebo.
Patients 1	Oxytocin	Participants will receive intranasal oxytocin 40 International Units (IU).

Primary Outcome Measures

Name	Time	Method
Number of patients with non-serious and serious adverse events	3 weeks

Trial Locations

Locations (1)

San Francisco General Hospital Opiate Treatment Outpatient Program; 🇺🇸 San Francisco, California, United States